Palmoplantar Pustular Psoriasis Efficacy and Safety wIth Secukinumab

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.

Was to demonstrate superiority of secukinumab compared to placebo in patients with moderate to severe chronic palmoplantar pustular psoriasis with respect to the palmoplantar pustulosis Psoriasis Area and Severity Index 75 response rate

A 52-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study of Subcutaneous Secukinumab to Demonstrate Efficacy as Assessed by Palmoplantar Pustulosis Psoriasis Area and Severity Index (ppPASI) at 16 Weeks of Treatment, Compared to Placebo, and to Assess Long-term Safety, Tolerability, and Efficacy in Subjects With Moderate to Severe Chronic Palmoplantar Pustular Psoriasis

70 patients with moderate to severe chronic palmoplantar pustular psoriasis will be treated with Secukinumab 300 mg subcutanous (s.c.) until Week 16. From Week 16 until Week 52 all patients and in addition half of the patients in the placebo arm that are non-responders to the placebo treatment are treated with Secucinumab 300 mg s.c. Efficacy and patient's safety will be compared separately in each group.

Biological: Secucinumab

Secucinumab will be used as 150 mg pre-filled syringes in a double-blinded fashion. Until Week 16 patients will perform a self-administration under the supervision of the investigator. After Week 16 patients will have regular office visits and apply the treatment under supervision of the investigator and in between office visits apply treatment at home. The investigator must emphazie compliance and instruct patients to take the treatment exactly as described.

Experimental: Secucinumab 150mg

70 patients with moderate to severe chronic palmoplantar pustular psoriasis will be treated with Secukinumab 150 mg subcutanous (s.c.) until Week 16. From Week 16 until Week 52 all patients and in addition half of the patients in the placebo arm that are non-responders to the placebo treatment are treated with Secucinumab 150 mg s.c. Efficacy and patient's safety will be compared separately in each group.

Biological: Secucinumab

Secucinumab will be used as 150 mg pre-filled syringes in a double-blinded fashion. Until Week 16 patients will perform a self-administration under the supervision of the investigator. After Week 16 patients will have regular office visits and apply the treatment under supervision of the investigator and in between office visits apply treatment at home. The investigator must emphazie compliance and instruct patients to take the treatment exactly as described.

Placebo Comparator: Placebo

70 patients with moderate to severe chronic palmoplantar pustular psoriasis will be treated with matching placebo subcutanous (s.c.) until Week 16. At week 16 non-responders to placebo treatment will be re-randomized 1:1 to both secukinumab treatment arms.

Primary endpoint is assessed by a Patient Related Outcome as response rate of patients to treatment measured by the palmoplantar pustulosis Psoriasis Area and Severity Index 75 (ppPASI 75). The percentage of subjects who archieve a 75% reduction in ppPASI score from Baseline to Week 16 is measured. The ppPASI is a modification of the PASI score and adjusted for palmoplantar pustular psoriasis by classifying and scoring erythema, scaling (desquamation) and pustules/vesicles. Both palms and both plants are scored from 0 to 4. The extent of involvement of each region of the body is scored from 0 to 6. The total maximum score is 72.

A secondary endpoint is assessed by a Patient Related Outcome as response rate of patients to treatment measured by the palmoplantar pustulosis Psoriasis Area and Severity Index (ppPASI). The mean change of ppPASI score from Baseline to Week 16 is measured. The ppPASI is a modification of the PASI score and adjusted for palmoplantar pustular psoriasis by classifying and scoring erythema, scaling (desquamation) and pustules/vesicles. Both palms and both plants are scored from 0 to 4. The extent of involvement of each region of the body is scored from 0 to 6. The total maximum score is 72.

A secondary endpoint is assessed by a Patient Related Outcome as response rate of patients to treatment measured by the palmoplantar pustulosis Psoriasis Area and Severity Index (ppPASI). The mean change of ppPASI score from Baseline to Week 52 is measured. The ppPASI is a modification of the PASI score and adjusted for palmoplantar pustular psoriasis by classifying and scoring erythema, scaling (desquamation) and pustules/vesicles. Both palms and both plants are scored from 0 to 4. The extent of involvement of each region of the body is scored from 0 to 6. The total maximum score is 72.

patient's safety [ Time Frame: Baseline to Week 60 ]

Clinical safety and tolerability of secukinumab treatment regimens as assessed by vital signs, clinical laboratory variables, electrocardiograms (ECGs), and adverse events monitoring are measured as number of events

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Palmoplantar pustular psoriasis for at least 6 months before Randomization

Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment and for 16 weeks after stopping treatment

Active ongoing inflammatory diseases other than psoriasis that might confound the evaluation of the benefit of secukinumab therapy

Use of any other investigational drugs within 4 weeks of study drug initiation or within a period of 5 half-lives of the investigational treatment, whichever is longer